Saw, Pneumatically Powered

Device Code: 5710

Product Code(s): KFK

Device Classification Information

Device Type ID5710
Device NameSaw, Pneumatically Powered
Regulation DescriptionSurgical Instrument Motors And Accessories/attachments.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type510(K) Exempt
CFR Regulation Number878.4820 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKFK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5710
DeviceSaw, Pneumatically Powered
Product CodeKFK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSurgical Instrument Motors And Accessories/attachments.
CFR Regulation Number878.4820 [🔎]
Device Problems
Electrical /Electronic Property Problem
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 21:11:12

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